We anticipate the application window for this opening will close on - 19 Sep 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

In this role, you will work with a team that monitors Medtronic’s surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.

Key Responsibilities:

This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.

People-centered, data-driven, connected. We're solving the world's biggest health challenges with healthcare technology. We fuse technology and research for groundbreaking solutions. From less-invasive surgery that minimizes a patient's downtime to the world’s smallest pacemaker, our technology transforms lives

Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies

Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries

Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements

Lead or leverage cross functional teams to evaluate, develop and manage projects for key business processes

Oversee and manage the operational aspects of ongoing projects and serves as liaison between project team and stakeholders

Assess project issues and supports project team in development of resolutions to meet goals and objectives.

Understand current and upcoming Medical Device Reporting (MDRs) and EU Vigilance Reporting requirements by regulatory bodies and ensure adequate implementation or regulations

Required Knowledge and Experience: 

Minimum Requirements:

Bachelor’s Degree with 7+ years of experience in Quality and/or Regulatory, including direct experience in MDR/vigilance systems implementation. OR Advanced degree with 5+ years of relevant experience in the same areas.

Nice to Have

• Demonstrated ability to collaborate and influence in a matrixed environment and to work effectively with in-house functional team
• Strong Regulatory Compliance experience – understanding, interpreting and implementing Regulatory changes into policies/processes Excellent verbal, written and presentation communication skills
• Proven ability to build and facilitate strong, productive working relationships with a wide variety of cross-functional and customer contacts
• Program management experience in the medical device, aerospace, automotive or other highly regulated industry
• Experience devising and implementing streamlined processes and strategic programs to improve efficiency, timeliness, and productivity
• Experience in leading within matrix organizations requiring strong influence management skills
• Change agent --willingness and ability to lead and institute change
• Influence management skills; experience working collaboratively at all levels in matrix environment to build and maintain the positive relationships required to accomplish organizational goals
• Excellent communication skills and interpersonal/team effectiveness with ability to succinctly and accurately communicate to various levels of management and employees
• Business acumen; ability to think and act from an overall “best for the business” perspective
• Results oriented; strong sense of urgency
• Strong analytical, planning, organization and time management skills to effectively develop and execute comprehensive programs and budgets
• Effective decision-making skills with ability to negotiate and balance decisions and priorities across needs